Clinical Research Associate

Job description

·  Job facts

Job Summary

Design, plan, coordinate and conduct all activities involved in initiating, monitoring, and completing clinical research studies in the clinical study sites. Ensures studies are recorded and reported in accordance with protocol, standard operating procedures, good clinical practices and other applicable regulatory requirements. Reviews and provides input into protocol, protocol revisions, WinCAEv definition, (e)CRF design, Study Reports and publications. Validates product performance claims, supply data for critical Regulatory submissions, define the functional and clinical utility of our products, and obtain the opinions and input regarding our products from laboratories or customers, who may be considered key opinion leaders.

Learning and developing professional expertise. Applies company policy and procedures to resolve a variety of issues. Works on projects of limited to moderate scope. Exercises judgement within defined procedures and practices. Receives general instructions on routine work, detailed instructions on new projects or assignments. Interacts with peers and stakeholders as required to complete tasks. Responsible for maintaining and continuously improving the quality system and achieving quality objectives through daily actions.

What you do

·  Performing site assessments and provide input to the site selection process
·  Driving site contracting, together with study managers
·  Ensuring that IRB/EC/Health Authority approvals are obtained and meet the associated regulatory requirements
·  Authoring the Study Monitoring Plan and execution of the plan in compliance with visit frequency and all assigned tasks
·  Planning and execution of the Study Logistics Plan, including delegation of activities to the Support Group, as appropriate.
·  Performing site initiation, interim monitoring, and site close out visits
·  Serving as key contact for study site personnel
·  Safeguarding safety (study subject and site personnel) and compliance to the Study Protocol, SOP(s), GxP, and all governing regulations via monitoring vigilance and communication, both on site and remotely, throughout the study
·  Performs Source Data Verification (SDV), generates queries, and oversees query resolution
·  Reconciles study files and prepares them for archiving

Who we are

Bei Roche leisten 94,000 Menschen in 100 Ländern Pionierarbeit im Gesundheitswesen. Gemeinsam haben wir uns zu einem weltweit führenden, forschungsorientierten Healthcare-Konzern entwickelt. Unser Erfolg baut auf Innovation, Neugier und Vielfalt.

Roche ist ein Arbeitgeber, der für Chancengleichheit steht und rechtswidrige Diskriminierung aufgrund von Hautfarbe, Religion, Geschlecht, sexueller Orientierung, Geschlechtsidentität und geschlechtlicher Äußerung, nationaler und ethnischer Herkunft, Abstammung, Alter, geistiger und körperlicher Beeinträchtigung, Krankheit, Familienstand, ehemaliger Militärzugehörigkeit oder anderer durch Gleichbehandlungsgesetze geschützter Eigenschaften ausdrücklich untersagt.

Desired profile

Who you are

·  Bachelor's degree in chemistry, biology, medical science, or relevant field
·  Excellent oral and written communication skills
·  Excellent planning, organizing, and interpersonal skills
·  Ability to make sound decisions and to analyze and solve problems, together with supervisor, if needed, and take responsibility for one's own actions
·  Demonstrated experience in computer skills to include Microsoft Office, Google, and basic templates
·  Ability to recognize and resolve obstacles/issues and deliver high quality work within timelines.

Preferred experience

·  Knowledge of applicable standards and regulations for clinical trials and lab conduct [International Conference of Harmonization Good Clinical Practice standards (ICH-GCP), FDA Regulations, and IVD Directives].
·  Practical experience in study monitoring according to global standards (ICH).
·  Knowledge of basic statistics.
·  Ability to work in local and global study teams, including virtual teams; cultural awareness.

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